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Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?

Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01212211
Acronym
NATRIPHAR
Enrollment
18
Registered
2010-09-30
Start date
2010-12-01
Completion date
2012-05-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

Hyponatremia; Sodium level, Falls, Gait, elderly

Brief summary

Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown. Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit. Symptoms related to hyponatremia can be very subtle and difficult to detect clinically. Twenty elderly patients, retirement homes residents, with serum sodium \< 135mEq/L will be included. They will be randomised. The physician will review the drug treatment of ten patients in coordination with the opinion of pharmacologists. Drug treatment for ten other patients wil remained unchanged during the three months of inclusion. Useful elements of the medical records of patients randomized to the experimental arm will be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice, subject to the attention of physician of retirement homes, give rise to a therapeutic approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical intervention will be evaluated by an objective biological criteria: serum sodium in the fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium and check the interest of correcting hyponatremia to improve postural capacities and eventually reduce the number of falls in the medium term (three months).

Interventions

OTHERchange in drug therapy

Change in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient over 65 years Resident of dependent elderly * Plasma sodium \<135 mmol / l less than a week, confirming earlier hyponatremia within a week to three month agreement given after patient information

Exclusion criteria

* Venous system does not allow sampling - Patient not taking medication-Dementia

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderlyFourth weekNormalization serum sodium between S0 and S4 (4 weeks after medical intervention)

Secondary

MeasureTime frameDescription
Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of fallsthree monthsChanges in serum sodium weekly S1, S2, S3 - Evolution of the score evaluation of postural control: the Timed Up and Go test (TUG) between therapeutic intervention and S4-comparison of the number of falls between the period three months before and three months after surgery Medical Decision to three months whether to maintain the drug therapy changed

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBlandine De la Gastine, MD

University Hospital, Caen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026